# China NMPA Product Recall - Streptococcal susceptibility indicator, BD Phoenix™ AST Indicator Solution

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-medical-devices-shanghai-co-ltd/65a2df5d-5b3f-48f7-8644-9d3ab77aa42e/
Source feed: China

> China NMPA product recall for Streptococcal susceptibility indicator, BD Phoenix™ AST Indicator Solution by Smith Medical Devices (Shanghai) Co., Ltd. published December 26, 2018. Recall level: Level 2 Recall. BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its BD Phoenix™ AS

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: BD Medical Devices (Shanghai) Co., Ltd. is voluntarily recalling its BD Phoenix™ AST Indicator Solution for Streptococcus pneumoniae.
- Company Name: Smith Medical Devices (Shanghai) Co., Ltd.
- Publication Date: 2018-12-26
- Product Name: Streptococcal susceptibility indicator, BD Phoenix™ AST Indicator Solution
- Recall Level: Level 2 Recall
- Recall Reason: When using certain batches of BD Phoenix™ assay plates inoculated with antimicrobial susceptibility indicator solution, test termination may occur within 45 minutes of placing the assay plate into the Phoenix assay instrument. Customers experiencing test termination will receive a special notification from the instrument: Insufficient indicator volume detected in the assay plate; the AST portion of the assay plate has terminated; the isolates should be retested.
- Discovering Company: BD Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Smith Medical Devices (Shanghai) Co., Ltd.
- Summary: BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its BD Phoenix™ AST Indicator Solution following customer feedback. The recall, publicly announced by the National Medical Products Administration (NMPA) on December 26, 2018, addresses a significant performance issue with the medical device.Customers reported that test plates inoculated with specific batches of the indicator solution experienced premature test termination, often within 45 minutes of placement in the Phoenix testing instrument. This malfunction resulted in an instrument notification indicating "Insufficient indicator dosage" and the termination of the AST portion of the test, necessitating retesting of the isolate.The affected product, registered under certificates such as Shanghai Food and Drug Administration Medical Device Registration Certificate 2018-314 and Registration Certificate No.: 20142405397, 20150096, is being recalled to ensure patient safety and reliable diagnostic results. The recall details, including specific models, specifications, and batch numbers, are further outlined in an attached Medical Device Recall Event Report Form. This action underscores the company's commitment to product quality and compliance with regulatory standards enforced by the NMPA.

Company: https://www.globalkeysolutions.net/companies/smith-medical-devices-shanghai-co-ltd/a4f694b0-5671-4759-922c-b6adb96ecceb/